The present invention was created as a solution to the problems commonly associated with batching, analyzing and viewing data from computerized and process control systems used in the manufacture of pharmaceutical products. Users were required to manually retrieve the data they wished to analyze and then perform complex, time-consuming and error-prone analyzation on that data. Often, different departments required different analyzation reports, further adding to an already complex situation. In some cases, quality issues were not found until weeks later, causing entire product lines to be scratched, and increasing costs.
The present invention consists of modules that allow for the customized batching, analyzation and viewing of data. By linking desktops with critical manufacturing and quality information from across an entire operation, many benefits can be achieved. Users can instantly discern the quality disposition of a batch or process run within seconds. Batch quality can be improved by automatic comparison of process data against recipe requirements, quality attributes and equipment specifications. Available in near real-time, analysis creates department-specific reports for each process and generate run summary data, useful for comparing and analyzing the critical process parameters in a given cycle for a specific piece of equipment over time. Department-specific reports allow each individual unit within the organization the ability to look at the same information, but displayed against the criteria specific to their individual needs. Slowly decaying equipment performance can be found in a matter of minutes by performing statistical analysis on historical data.